BEUDAMED
    FDA Adverse Event Other Summary report: N

    V500, SAVINA AND VENTILATORS OF EVITA FAMILY

    MDR report key: 2010379 · Received February 18, 2011

    Report

    Report Number
    9611500-2011-00003
    Event Type
    Other
    Date Received
    February 18, 2011
    Date of Event
    January 31, 2010
    Report Date
    February 17, 2011
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K961687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) K003068. DRAGER INTENSIVE CARE VENTILATORS ARE NOT CONTAMINATED WITH FUNGI WHEN BEING DELIVERED TO THE CUSTOMER AND THEY DO NOT CONTENT MATERIAL WHICH SUPPORTS ACCRETION OF FUNGI. CLEANING RECOMMENDATIONS FOR THE DRAGER VENTILATORS (WIPE DISINFECTION OF SURFACES) ARE DESCRIBED IN THE INSTRUCTIONS FOR USE. THE RECOMMENDATIONS ARE EFFECTIVE FOR MANY YEARS. NO SIMILAR REPORT IS KNOWN. FANS IN MEDICAL DEVICES ARE USED AS A STATE OF THE ART TO BRING THE HEAT GENERATED BY ELECTRIC COMPONENTS OUT OF THE MEDICAL DEVICES. CLEANING AND DISINFECTION OF ALL OBJECTS AND DEVICES WHICH ARE USED WITHIN THE INTENSIVE CARE UNITS ARE IN THE RESPONSIBILITY OF THE OPERATOR. STANDARDS FOR CLEANING AND DISINFECTION PROCEDURES SHOULD BE ESTABLISHED IN INTENSIVE CARE UNITS TO AVOID ANY TYPES OF INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURFACE OF COOLING FANS (BLADES AND GRIDS) OF THE DRAGER VENTILATORS WERE FOUND TO BE CONTAMINATED BY FUNGUS (AMONG WHICH MURORALS) AND THAT SPORES HAVE BEEN DISPERSED IN THE AIR. THIS POLLUTION MIGHT HAVE INFECTED 3 PTS WITH MURORALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V500, SAVINA AND VENTILATORS OF EVITA FAMILY VENTILATORS, CONTINUOUS CBK DRAGER MEDICAL GMBH VARIOUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization